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Excipient

ICH Q7 GMP Manufactured Product

DEXTRAN POWDER, MW 10,000

GMP, Excipient
Product Code: D010-3201

Minimum Order Quantity: 50kg
Lead Time: 3-6 months

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Product Code: D010-3201
Suitable for use as a cGMP chemical in pharmaceutical manufacturing processes and products.

Excipient Grade Dextran Powder, 10,000 MW, is a more refined and purified form of hydrolyzed, higher-molecular-weight Dextran polymer powder. Dextran Powder, MW 10,000 is a glucose polymer made by the fermentation of sugar by the bacteria Leuconostoc Mesenteroides. It is defined as a “branched poly-α-d-glucoside,” having predominant C-1 to C-6 bonds. Dextran polymers are freely soluble in water and other solvents, biodegradable and biocompatible, and have a wide range of applications in the Life Sciences.

Formula: [C6H10O5]n
M.W.:
10,000 g/mol
CAS #:
9004-54-0

Product Specifications

ANALYSIS

SPECIFICATIONS

Appearance (Color)  

White to Slightly Off-White Powder

Chloride

 

< = 1%

Cold Water Solubility (1%)

Passes Test

Absorbance (10%) 375 nm

< = 0.20 OD Unit

Heavy Metals (Pb)

< = 20 ppm

Intrinsic Viscosity (1%), 37°C

0.08 - 0.11

Loss on Drying

< = 7.0%

pH (10%)

 4.5 - 7.0

Residue on Ignition

< = 2.0%

Specific Rotation (2%), 20°C

> = +148°

 

Printable Version

Key Product Features:

  • Our Dextran Powders are produced, refined and purified at our facility in Scarborough, Ontario, Canada, and then further purified at our FDA registered, cGMP plant in Bangor, PA, USA.
  • Appears as a white to slightly off-white powder
  • Manufactured in accordance with ICH Q7
  • Manufactured in an enzyme free, hormone free, and animal free environment
  • Contains no known major food allergens (as defined by FDA and WHO)
  • The final product and its raw materials are not derived from nor come into contact with animal parts, animal products, and/or animal byproducts or derivatives.
  • Is not subject to genetic modification
  • Synonyms: 2,3,4,5-tetrahydroxy-6-[3,4,5-trihydroxy-6-[[3,4,5-trihydroxy-6-(hydroxymethyl) oxan-2-yl] oxymethyl] oxan-2-yl] oxyhexanal

Storage & Shipping:

Refer to SDS.

Shelf-Life Policy:

Unless otherwise noted on the Shelf-Life Statement and CoA, this product has a 2-year retest date supported by a 3-year ICH Q1 Stability Study (if one is completed).

Package Sizes:

1kg, 5kg, 10kg, 25kg, and 50kg 

Bulk GMP Fine Chemicals exclusively manufactured in North America

American Manufactured - FDA Registered GMP Facilities: Parenteral Excipients, GMP Small Molecule Intermediates, GMP Biological Buffers, Parenteral Carbohydrates, GMP Chlorinated Amino Acids, GMP Solutions in Sterile Single Use Packaging and other Reagent & GMP Fine Chemicals.